(87 days)
The Spinal USA Anterior Lumbar Plate System is intended for use as an anteriorly placed supplemental fixation device via the lateral or anterolateral surgical approach above the bifurcation of the great vessel or via the anterior surgical approach, below the bifurcation of the great vessels. The device is a temporary fixation device until fusion is achieved. The Spinal USA Anterior Lumbar Plate System is intended for anterior lumbar (L1-S1) fixation for the following indications: degenerative disc disease (DDD), defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion. The Spinal USA Anterior Lumbar Plate System is intended to be used with autograft as an adjunct to fusion.
The Spinal USA Anterior Lumbar Plate System consists of a range of plate and screw sizes. The plates come in sizes of: 21 mm, 23 mm, 27 mm. The screws come in 5.0mm and 5.5mm diameters and the screw lengths are 25mm, 30mm. The plates attach to the anterior or anterolateral aspect of the vertebral body of the lumbar/lumbosacral spine (levels L1-S1) and provide stabilization to permit the biological process of spinal fusion to occur. All components are made from medical grade titanium or titanium alloy described by such standards as ASTM F136 or ISO5832-3. The products are supplied clean and "NON-STERILE".
The provided text is a 510(k) summary for the Spinal USA Anterior Lumbar Plate System. This type of document is for a medical device that requires premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
The 510(k) summary does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the context of AI/machine learning. Instead, it focuses on demonstrating substantial equivalence to a predicate device based on performance data relevant to its mechanical and material properties, and its intended use as a spinal fixation device.
Therefore, I cannot provide the requested information, which pertains to AI device evaluation, from this document. The document describes a traditional medical device (spinal plate system) and its regulatory clearance process, not an AI/machine learning component.
To be clear, the document does NOT contain:
- A table of acceptance criteria and reported device performance related to AI.
- Sample sizes or data provenance for a test set (in an AI context).
- Number or qualifications of experts for establishing ground truth (in an AI context).
- Adjudication method for a test set (in an AI context).
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study for AI.
- Information about a standalone algorithm performance study.
- Type of ground truth used (in an AI context).
- Sample size for a training set (in an AI context).
- How ground truth for a training set was established (in an AI context).
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.